Integrated handle assembly for anchor delivery system

ABSTRACT

Integrated systems and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application No.11/837,614, now U.S. Pat. No. 7,766,923, entitled Integrated HandleAssembly For Anchor Delivery System, filed Aug. 13, 2007, which is acontinuation-in-part of U.S. patent application No. 11/492,690, now U.S.Pat. No. 7,896,891, entitled Apparatus and Method for Manipulating orRetracting Tissue and Anatomical Structure, filed on Jul. 24, 2006,which is a continuation-in-part of U.S. patent application Ser. No.11/318,246, now U.S. Pat. No. 7,645,246, entitled Devices, Systems andMethods for Retracting, Lifting, Compressing, Supporting orRepositioning Tissues or Anatomical Structures, filed on Dec. 22, 2005,which is a continuation-in-part of U.S. patent application Ser. No.11/134,870, now U.S. Pat. No. 7,758,594, entitled Devices, Systems andMethods for Treating Benign Prostatic Hyperplasia and Other Conditions,filed on May 20, 2005, the entire disclosures of which are expresslyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to integrated systems and associated methods formanipulating or retracting tissues and anatomical or other structureswithin the body of human or animal subjects for the purpose of treatingdiseases or disorders and/or for cosmetic or reconstructive or otherpurposes.

BACKGROUND OF THE INVENTION

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., organs, ligaments, tendons, muscles,tumors, cysts, fat pads, etc.) within the body of a human or animalsubject. Such procedures are often carried out for the purpose oftreating or palliating the effects of diseases or disorders (e.g.,hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses,herniations, stenoses, constrictions, compressions, transpositions,congenital malformations, etc.) and/or for cosmetic purposes (e.g., facelifts, breast lifts, brow lifts, etc.) and/or for research anddevelopment purposes (e.g., to create animal models that mimic variouspathological conditions). In many of these procedures, surgicalincisions are made in the body and laborious surgical dissection isperformed to access and expose the affected tissues or anatomicalstructures. Thereafter, in some cases, the affected tissues oranatomical structures are removed or excised. In other cases, variousnatural or man made materials are used to lift, sling, reposition orcompress the affected tissues.

Benign Prostatic Hyperplasia (BPH)

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockersblock that activity of alpha-1a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1a-adrenergic receptorscauses prostatic smooth muscle relaxation. This in turn reduces urethralresistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todihydrotestosterone. Dihydrotestosterone causes growth of epithelialcells in the prostate gland. Thus 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and hence reducethe volume of the prostate gland which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practicedsurgical procedure implemented for the treatment of BPH. In thisprocedure, prostatic urethral obstruction is reduced by removing most ofthe prostatic urethra and a sizeable volume of the surrounding prostategland. This is carried out under general or spinal anesthesia. In thisprocedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus the region of urethra that is blocked bythe surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases are deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam etc.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, aneodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablatetissue by causing coagulation necrosis. The procedure is performed undervisual guidance. In HoLEP, a holmium: Yttrium-aluminum-garnet laser isused for direct contact ablation of tissue. Both these techniques areused to remove tissue obstructing the urethral passage to reduce theseverity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate glandthus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which in turn causes the prostate gland toshrink. Shrinkage of the prostate gland reduces the degree of squeezingof the urethra by the prostate thus reducing the severity of BPHsymptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only a modest effect on BPH symptoms and the flow rate of urine. Inaddition, anti-androgens, such as 5-alpha-reductase, require months oftherapy before LUTS improvements are observed. Surgical treatments ofBPH carry a risk of complications including erectile dysfunction;retrograde ejaculation; urinary incontinence; complications related toanesthesia; damage to the penis or urethra, need for a repeat surgeryetc. Even TURP, which is the gold standard in treatment of BPH, carriesa high risk of complications. Adverse events associated with thisprocedure are reported to include retrograde ejaculation (65% ofpatients), post-operative irritation (15%), erectile dysfunction (10%),need for transfusion (8%), bladder neck constriction (7%), infection(6%), significant hematuria (6%), acute urinary retention (5%), need forsecondary procedure (5%), and incontinence (3%) Typical recovery fromTURP involves several days of inpatient hospital treatment with anindwelling urethral catheter, followed by several weeks in whichobstructive symptoms are relieved but there is pain or discomfort duringmicturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries have made their removal quite difficult andinvasive.

Thus the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Urinary Incontinence (UI)

Many women experience loss of bladder control following childbirth or inold age. This condition is broadly referred to as urinary incontinence(UI). The severity of UI varies and, in severe cases, the disorder canbe totally debilitating, keeping the patient largely homebound. It isusually associated with a cystocele, which results from sagging of theneck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengtheningexercises (e.g., Kegel exercises), drug therapy, electrical stimulationof the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option.In general, the surgical procedures used to treat UI attempt to lift andsupport the bladder so that the bladder and urethra are returned totheir normal positions within the pelvic cavity. The two most commonways of performing these surgeries is through incisions formed in theabdominal wall or though the wall of the vagina.

A number of different surgical procedures have been used to treat UI.The names for these procedures include the Birch Procedure,Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-VaginalTape Procedure, Urethral Suspension, Vesicourethral Suspension. Theseprocedures generally fall into two categories, namely a) retropubicsuspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made inthe abdominal wall a few inches below the navel and a network ofconnectors are placed to support the bladder neck. The connectors areanchored to the pubic bone and to other structures within the pelvis,essentially forming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of thevagina and a sling is crafted of either natural tissue or synthetic(man-made) material to support the bladder neck. Both ends of the slingmay be attached to the pubic bone or tied in front of the abdomen justabove the pubic bone. In some sling procedures a synthetic tape is usedto form the sling and the ends of the synthetic tape are not tied butrather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significantdiscomfort as the incisions heal and may require a Foley or supra-pubicurinary catheter to remain in place for at least several days followingthe surgery. Thus, there exists a need in the art for the development ofminimally invasive (e.g., non-incisional) procedures for the treatmentof UI with less postoperative discomfort and less requirement forpost-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, etc. havebecome commonplace. In many cases, these procedures are performed bycreating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, other muscles) to hold the repositioned tissuesin their new (e.g., lifted) position. In some cases excess skin may alsobe removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,connector suspension lifts have been developed where one end of astandard or modified connector thread is attached to muscle and theother end is anchored to bone, periostium or another structure to liftand reposition the tissues as desired. Some of these connectorsuspension techniques have been performed through cannulas or needlesinserted though relatively small incisions of puncture wounds.

For example, barbed threads known as Aptos threads may be insertedthrough a hollow trocar and used to lift tissues of the face in aprocedure that is performed commercially under the name Featherlift™(KMI, Inc. 2550 West Rowland Anaheim, Calif. 92804).

Another barbed thread that is useable for minimally invasive cosmeticlifting procedures is marketed under the name Contour Threads™ (SurgicalSpecialties Corporation, 100 Dennis Drive Reading, Pa. 19606).

There remains a need for the development of new devices and methods thatmay be used for various procedures where it is desired to lift,compress, support or reposition tissues or organs within the body withless intraoperative trauma, less post-operative discomfort and/orshorter recovery times. Moreover, there is an opportunity to takeadvantage of aspects of anatomy and to employ structures configured tocooperate with such anatomy. In this way, an interventional site withina patient's body can be more easily accessed as well as heal more easilyand completely and the body can more readily return to normal operation.Furthermore, there is a distinct need for an integrated system foraccomplishing various steps involved in both implanting and assemblingdevices at interventional sites.

The present invention addresses these and other needs.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed towardsan apparatus and method for deploying an anchor assembly within apatient's body. In a particular aspect, the present invention isdirected towards various embodiments of integrated anchor deliverydevices. In one aspect, the delivery devices accomplish the delivery ofa first or distal anchor assembly component at a first location within apatient's body and the delivery of a second or proximal anchor assemblycomponent at a second location within the patient. The devices alsoaccomplish imparting a tension during delivery and a tension betweenimplanted anchor components as well as cutting the anchor assembly to adesired length and assembling the proximal anchor in situ. The procedurecan be viewed employing a scope incorporated into the device.

The present invention also contemplates a reversible procedure as wellas an anchor assembly with sufficient visibility when viewedultrasonically. In one aspect, the implant procedure is reversible bysevering a connector of an anchor assembly and removing an anchor of theanchor assembly such as by so removing a proximally placed anchorpreviously implanted in an urethra. Moreover, the anchor assemblies canbe formed of structures facilitating ultrasound viewing.

The anchor assembly can be configured to accomplish retracting, lifting,compressing, supporting or repositioning tissue within the body of ahuman or animal subject. Moreover, the apparatus configured to deploythe anchor assembly as well as the anchor assembly itself are configuredto complement and cooperate with body anatomy. Further, the anchorassembly may be coated or imbedded with therapeutic or diagnosticsubstances or such substances can be introduced into or near aninterventional site by the anchor deployment device or other structure.

In another aspect, structure of the anchor assembly is designed toinvaginate within or complement tissue anatomy to thereby facilitatehealing and minimize infection risk. Moreover, the anchor deliverydevice includes structure to form desired angles between an extendedposition of the needle assembly relative to the device. Additionally, itis contemplated that a distal end portion of the anchor delivery devicebe configured to facilitate the testing of the effectiveness ofpositioning of an anchor assembly. In this regard, the distal endportion is configured in a manner to mimic the effect a second anchormember will have prior to its implantation.

In one embodiment, the anchor delivery device includes a handle assemblywith a plurality of actuators or triggers attached thereto. A firstactuator is associated with a body of the handle assembly and isoperatively attached to the needle assembly and structure that advancesthe first anchor member. A second actuator attached to the handleassembly is operatively associated with structure that accomplishesassembling first and second parts of the second anchor member to eachother and to the connector member. Also, the handle assembly is equippedwith a third actuator that is configured in one contemplated embodiment,to effect the cutting of the anchor assembly to a desired length anddeployment of the structure at an interventional site.

In a specific embodiment, the anchor delivery device includes agenerally elongate tubular housing assembly member extending distallyfrom a handle assembly including a plurality of actuators. The proximalend of the handle assembly is equipped with mounting structureconfigured to receive a telescope or other endoscopic viewinginstrument. A bore sized to receive the telescope extends distallythrough a body of the handle assembly and continues through an outertubular cover member forming the generally elongate member. Housedwithin the tubular housing assembly are a telescope tube having aninterior defining a distal section of the bore sized to receive thetelescope, an upper tubular member assembly sized to receive a pluralityof first components of the second anchor member and a needle housingconfigured to receive the needle assembly. Moreover, the generallyelongate tubular housing includes a terminal end portion defined by anose assembly which retains a plurality of second components of thesecond anchor members.

Moreover, in a preferred embodiment the first anchor member includes abody having a generally tubular portion from which a first partialcylinder portion extends proximally. Attached to a midpoint of the bodyis a spring in the form of a second partial cylinder portion that iscomplementary to the first partial cylinder portion. Extending from theopposite end of the spring is a generally tubular collar. In acompressed configuration, the first anchor member defines a generallystraight member and when unconstrained, the first anchor member formsgenerally a T-structure with the body defining the cross-member of theT-structure.

Further, in the preferred embodiment, the first part of the secondanchor member is embodied in a pin having a first distal end equippedwith a pair of spaced arms and a second proximal end including groovesfacilitating pushability. The arms of the first distal end are designedto receive the connector structure and to be placed into lockingengagement with the second part of the second anchor member. The secondpart has a generally tubular configuration and an internal bore sized toreceive the first component.

The present invention also contemplates a number of alternative designsfor the first and second anchor members and connectors as well asstructures for advancing and deploying the anchor members and cuttingthe connector. Additionally, it is contemplated that various embodimentscan incorporate one or more sensors into the deployment device tofacilitate proper positioning of the device and anchor deployment.

Moreover, various alternative methods of use are also contemplated. Thatis, in some applications of the invention, the invention may be used tofacilitate volitional or non-volitional flow of a body fluid through abody lumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, organ or graft, perform a cosmetic lifting orrepositioning procedure, form anastomotic connections, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure. Also,the invention has a myriad of other potential surgical, therapeutic,cosmetic or reconstructive applications, such as where a tissue, organ,graft or other material requires retracting, lifting, repositioning,compression or support.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view, depicting an integrated anchor deploymentdevice;

FIG. 2A is a cross-sectional view, depicting a distal end portion of thedevice of FIG. 1;

FIG. 2B is a cross-sectional view, depicting the implantation of anchorassemblies at an interventional site;

FIG. 2C is an enlarged view, depicting one anchor component of theassemblies shown in FIG. 2B;

FIG. 2D is a partial perspective view, depicting an elongate tubeassembly of the device of FIG. 1 without the outer sheath and detachedfrom the nose assembly and handle assembly;

FIG. 2E is a cross-sectional view, depicting a portion of a handleassembly of the device of FIG. 1;

FIG. 2F is a cross-sectional view, depicting further details of thedevice of FIG. 2C in addition to a cross-sectional view of a portion ofthe tubular housing assembly;

FIG. 3A is a perspective view, depicting a first anchor member of ananchor assembly of the present invention shown in a substantiallystraight configuration;

FIG. 3B is a perspective view, depicting the first member of FIG. 3A ina deployed or flipped configuration;

FIG. 3C is a perspective view, depicting a first component of a secondanchor member of an anchor assembly of the present invention;

FIG. 3D is a perspective view, depicting a second component of a secondanchor member of an anchor assembly of the present invention;

FIG. 3E is a perspective view, depicting a connector component with aplurality of first anchor members of the anchor assembly disposedthereon;

FIG. 3F is a perspective view, depicting an assembled anchor assembly;

FIG. 3G is a perspective view, depicting a coined connector;

FIG. 3H is a perspective view, depicting a connector equipped withraised portions;

FIG. 3I is a perspective view, depicting a connector equipped withcrimped components;

FIG. 4A is a perspective view, depicting an alternate embodiment of adistal component of an anchor assembly;

FIG. 4B is a perspective view, depicting the distal component of FIG. 4Ain a flipped configuration;

FIG. 4C is a perspective view, depicting another alternate embodiment ofa distal component of an anchor assembly;

FIG. 4D is a perspective view, depicting the distal component of FIG. 4Cin a flipped configuration;

FIG. 4E is a perspective view, depicting yet another alternateembodiment of a distal component of an anchor assembly;

FIG. 4F is a perspective view, depicting the distal component of FIG. 4Ein a flipped configuration;

FIG. 4G is a perspective view, depicting a distal component of an anchorassembly with a first embodiment of a tail section;

FIG. 4H is a perspective view, depicting a distal component of an anchorassembly with a second embodiment of a tail section;

FIG. 4I is a perspective view, depicting a distal component of an anchorassembly with a third embodiment of a tail section;

FIG. 4J is a perspective view, depicting yet another embodiment of adistal component;

FIG. 5A is a cross-sectional view, depicting a first step of treating aprostate gland using the present invention;

FIG. 5B is a cross-sectional view, depicting a portion of the anchordeployment device of FIG. 1 with the first actuator pivoted toward thehandle assembly;

FIG. 5C is a cross-sectional view, depicting further internal mechanismsof the handle for accomplishing the advancement of the needle assembly;

FIG. 5D is a perspective view, depicting the distal end portion of theanchor deployment device and the lateral advancement of a needleassembly;

FIG. 5E is a cross-sectional view, depicting a second step of treating aprostate gland using the present invention;

FIG. 5F is a perspective view, depicting the partial retraction of theneedle assembly;

FIG. 5G is a cross-sectional view, depicting the assembly of FIG. 5D;

FIG. 5H is a perspective view, depicting the complete retraction of theneedle assembly;

FIGS. 5I and J are cross-sectional views, depicting further steps of amethod of treating a prostate gland using the present invention;

FIG. 5K is an enlarged perspective view, depicting one embodiment of afeeding mechanism for the distal component;

FIG. 6A is an elevation view, depicting one alternative approach forcontrolling the advancement and deployment of an anchor component;

FIG. 6B is an elevation view, depicting a first configuration of theanchor of FIG. 6A after release from the advancement substructure.

FIG. 6C is an elevation view, depicting a second configuration of theanchor of FIG. 6A after release from the advancement substructure.

FIG. 6D is a perspective view, depicting an alternate embodiment of apusher device;

FIG. 6E is a perspective view, depicting a needle and pusher assemblyconfigured for side loading of an anchor component;

FIG. 6F is a perspective view, depicting an alternate embodiment of apusher assembly;

FIG. 6G is a perspective view, depicting the pusher assembly of FIG. 6Fand a complementary needle assembly;

FIG. 7A is a cross-sectional view, depicting an anchor loaded in aprotective cover;

FIG. 7B is a cross-sectional view, depicting a pusher cartridge in aloaded position;

FIG. 7C is a cross-sectional view, depicting the cartridge of FIG. 7A inan anchor deployed position;

FIG. 7D is an elevation view, depicting an anchor cartridge assembly;

FIG. 7E is a perspective view, depicting a needle assembly equipped witha sensor;

FIG. 8A is a cross-sectional view, depicting the pivoting of the secondactuator with respect to the handle;

FIG. 8B is an isometric view, depicting internal components operativelyassociated with the second actuator and with other components of theanchor deployment device removed;

FIG. 8C is a partial cross-sectional view, depicting a distal endportion of the integrated anchor deployment device of FIG. 8A;

FIG. 8D is a partial cross-sectional view, depicting the deploymentdevice of FIG. 8C with a second component of the second anchor memberbeing advanced toward a first component of the second anchor member;

FIG. 8E is a perspective view, depicting the deployment device of FIG.8B with the second component completely advanced into locking engagementwith the first component;

FIG. 9A is an enlarged perspective view, depicting a first step injoining the first and second components of the second anchor member;

FIG. 9B is an enlarged perspective view, depicting a second step injoining the first and second components of the second anchor member;

FIG. 9C is an enlarged perspective view, depicting a third step injoining the first and second components of the second anchor member;

FIG. 9D is an enlarged perspective view, depicting a first step in analternate approach in joining the first and second components of thesecond anchor member;

FIG. 9E is an enlarged perspective view, depicting a second step in thealternate approach in joining the first and second components of thesecond anchor member;

FIG. 9F is an enlarged perspective view, depicting a third step in thealternate approach in joining the first and second components of thesecond anchor member;

FIG. 9G is a perspective view, depicting another alternate embodiment ofthe first and second components of the second anchor member;

FIG. 9H is a cross-sectional view, depicting an interior of the assemblyshown in FIG. 9G;

FIG. 9I is a perspective view, depicting yet another alternativeembodiment of the first and second components of the second anchormember;

FIG. 9J is a perspective view, depicting yet another embodiment of thesecond anchor member;

FIG. 9K is a perspective view, depicting a further embodiment of thesecond anchor member;

FIG. 9L is a perspective view, depicting yet a further embodiment of thesecond anchor member;

FIG. 9M is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9N is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9O is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9P is a perspective view, depicting the embodiment of FIG. 9O in anassembled form;

FIG. 9Q is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9R is a perspective view, depicting the embodiment of FIG. 9Q in anassembled form;

FIG. 9S is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9T is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9U is a perspective view, depicting the embodiment of FIG. 9T in anassembled form;

FIG. 9V is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9W is a perspective view, depicting the embodiment of FIG. 9V in anassembled form;

FIG. 9X is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9Y is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9Z is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AA is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AB is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AC is a perspective view, depicting the embodiment of FIG. 9AC ina compressed form;

FIG. 9AD is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AE is a perspective view, depicting the embodiment of FIG. 9AD ina compressed form;

FIG. 9AF is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AG is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AH is a perspective view, depicting the embodiment of FIG. 9AG inan open configuration;

FIG. 9AI is a perspective view, depicting another embodiment of thesecond anchor member in combination with a forming anvil;

FIG. 9AJ is a perspective view, depicting another embodiment of thesecond anchor member in combination with a forming anvil;

FIG. 9AK is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AL is a perspective view, depicting another embodiment of thesecond anchor member;

FIG. 9AM is a perspective view, depicting the embodiment of FIG. 9AL inan open configuration;

FIG. 9AN is a perspective view, depicting another embodiment of thesecond anchor member shown in its flattened configuration;

FIG. 9AO is a perspective view, depicting another embodiment of thesecond anchor member shown in its flattened configuration;

FIGS. 10A-B are cross-sectional views, depicting yet further stepsinvolved in treating a prostate gland using the present invention;

FIG. 11A is a cross-sectional view, depicting a first step in analternative approach to anchor assembly and deployment;

FIG. 11B is a cross-sectional view, depicting a second step in analternative approach to anchor assembly and deployment;

FIG. 11C is a cross-sectional view, depicting a third step in analternative approach to anchor assembly and deployment;

FIG. 12A is a perspective view, depicting structure configured to aligncomponents of the anchor assembly;

FIG. 12B is a cross-sectional view, depicting the structure of FIG. 12A;

FIG. 13A is a partial cross-sectional view, depicting a first step in analternative approach to implanting an integrated anchor assembly;

FIG. 13B is a partial cross-sectional view, depicting a second step inan alternative approach to implanting the integrated anchor assembly ofFIG. 13A;

FIG. 13C is a perspective view, depicting a third step in an alternativeapproach to implanting the integrated anchor assembly of FIG. 13A;

FIG. 13D is a perspective view, depicting yet another embodiment of anintegrated anchor;

FIG. 13E is an elevation view, depicting the anchor of FIG. 13D in aflipped configuration;

FIG. 13F is an elevation view, depicting the anchor of FIG. 13D in aflat configuration.

FIG. 14A is a perspective view, depicting one preferred embodiment of afirst anchor member of an anchor assembly of the present matter;

FIG. 14B is a side view, depicting the first anchor member of FIG. 14Aattached to a connecting member;

FIG. 14C is a perspective view, depicting components of one of thepreferred embodiments of the second anchor member in a configurationprior to assembly;

FIG. 14D is a perspective view, depicting an assembled second anchormember of the present invention attached to a connecting member;

FIG. 15A is a perspective view, depicting an alternate embodiment of anintegrated anchor deployment device;

FIG. 15B is a perspective view, depicting the device of FIG. 15A with anouter handle casing removed;

FIG. 15C is a side view, depicting the device of FIG. 15B with an outersleeve removed;

FIG. 15D is a side view, depicting the device of FIG. 15C with a topmount trigger depressed;

FIG. 15E is a side view, depicting the device of 15D with the top mounttrigger further depressed;

FIG. 15F is a side view, depicting the device of FIG. 15B with a secondtrigger in a default position;

FIG. 15G is a side view, depicting the device of FIG. 15F with thesecond trigger in a depressed position;

FIG. 15H is a side view, depicting an alternate embodiment of the devicedepicted in FIG. 15B.

FIG. 16A is a perspective view, depicting yet another embodiment of anintegrated anchor delivery device;

FIG. 16B is a perspective view, depicting the integrated anchor deliverydevice of FIG. 16A with a first cover removed;

FIG. 16C is a perspective view, depicting the integrated anchor deliverydevice of FIG. 16B with a second cover removed;

FIG. 16D is a perspective view, depicting the device of FIG. 16C rotated180 degrees;

FIG. 16E is a perspective view, depicting the device of FIG. 16D with afirst trigger activated;

FIG. 16F is a perspective view, depicting the device of FIG. 16C with asecond trigger activated; and

FIG. 16G is a perspective view, depicting the device of FIG. 16F with anupper lever activated.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present invention is embodied in a device configured todeliver anchor assemblies within a patient's body. As stated, thepresent invention can be employed for various medical purposes includingbut not limited to retracting, lifting, compressing, supporting orrepositioning tissues, organs, anatomical structures, grafts or othermaterial found within a patient's body. Such tissue manipulation isintended to facilitate the treatment of diseases or disorders. Moreover,the disclosed invention has applications in cosmetic or reconstructionpurposes or in areas relating the development or research of medicaltreatments.

In one particular aspect, the anchor assembly of the present inventionis contemplated to be formed of a structure which is visible byultrasound. Accordingly, the anchor assembly can be viewed duringultrasonic body scans such as during normal trans-rectal ultrasound whena medical professional is conducting diagnoses or treatment associatedwith conditions like prostate cancer.

In such applications, one portion of an anchor assembly is positionedand implanted against a first section of anatomy. A second portion ofthe anchor assembly is then positioned and implanted adjacent a secondsection of anatomy for the purpose of retracting, lifting, compressing,supporting or repositioning the second section of anatomy with respectto the first section of anatomy. It is also to be recognized that both afirst and second portion of the anchor assembly can be configured toaccomplish the desired retracting, lifting, compressing, supporting orrepositioning of anatomy due to tension supplied thereto via a connectorassembly affixed to the first and second portions of the anchorassembly.

Referring now to FIG. 1, there is shown one embodiment of an integratedanchor delivery device 20. This device is configured to includestructure that is capable of both gaining access to an interventionalsite as well as assembling and implanting an anchor device, anchorassembly within a patient's body. The device further includes structureconfigured to receive a conventional remote viewing device (e.g., anendoscope) so that the steps being performed at the interventional sitecan be observed.

The integrated anchor delivery device 20 includes a handle assembly 22and a tubular housing assembly 24 extending from the handle assembly 22.The handle assembly 22 is sized and shaped to fit comfortably within anoperator's hand and can be formed from conventional materials.

The proximal end of the delivery device 20 includes a mount 26 forreceiving an endoscope or telescope 28 or other imaging device. Themount 26 includes an internal bore (not shown) sized and shaped toreceive the telescope 28. As indicated, the telescope 28 is intended toprovide the operator with the ability to view the operation of thedelivery device 20 at an interventional site.

The handle assembly 22 of the delivery device 20 also includes aplurality of activators or triggers associated with the handle assembly22. The body 30 includes a first or upper portion 32 extending generallyperpendicularly with respect to a second or lower portion 34. The secondportion is intended to be sized and shaped to fit within the palm of anoperator's hand. Pivotably affixed to the second portion 34 is a firstactuator 36. Although it can come in a myriad of forms, the firstactuator 36 includes a hooped portion sized and shaped to receive one ormore fingers of the operator's hand. The hooped portion extends from anarm which is pivotably connected to the handle 22, the arm and hoopedportion defining an acute angle with respect to the second portion 34 ofthe handle assembly 22 when inactivated. As will be described in moredetail below, the first actuator 36 is operatively associated with aneedle assembly and structure configured to advance and place a firstcomponent of an anchor assembly at an interventional site.

A second trigger or actuator 38 is pivotably connected adjacent thefirst body portion 32. Although it can come in a myriad of forms, thesecond actuator 38 defines a generally finger-like projection and ispositioned longitudinally distally from the body 30 with respect to thefirst actuator 36. The second actuator 38 also defines an acute anglerespecting the second portion 34 of the handle assembly 22 and is sizedand shaped to comfortably receive one or more fingers of the operator.Upon actuation, the second actuator 38 is configured to accomplish theassembly of an anchor device by attaching a second anchor component to aconnector affixed to the first anchor component.

A third trigger or actuator 40 is connected and configured to pivotablyrotate with respect to a top side of upper body portion 30. Although itcan come in a myriad of forms, in one embodiment, the third actuator 40defines a relatively straight member with a rounded substructure formedat its free terminal end. In this way, the third actuator 40 is easilymanipulated by a free digit of the operator's hand. The third actuator40 rotates from a forward position where it forms an acute angle withthe tubular housing assembly 24 to a rearward position where the memberdefines an obtuse angle with respect to the tubular housing assembly 24.In one embodiment, the third actuator 40 is intended to retract portionsof the tubular housing assembly 24 as well as accomplish cutting theconnector of the anchor assembly and deploying the anchor assembly at aninterventional site.

As stated, the tubular housing assembly 24 extends from the handleassembly 22. In one aspect, the tubular housing assembly 24 is mountedto a front face of the upper portion 32 of the handle assembly 22 andextends parallel to a longitudinal axis of the upper portion 32. At itsproximal end, the tubular housing assembly 24 includes a mount 42 fromwhich an outer sheath 44 extends in a distal direction. The mount 42includes one or more conventional stop cock assemblies 46 which providefluid communication with an interior of the tubular housing assembly.One stop cock assembly 46 is intended to provide the anchor deliverydevice 20 with a continuous flow irrigation. Another stop cock 46 iscontemplated to be used to accomplish a suction function through thedevice. Either of these assemblies can further be employed to delivertherapeutic or diagnostic substances to the interventional site. Forexample, in a procedure to treat a prostate gland, substances that causethe prostate to decrease in size such as 5-alpha-reductase inhibitorscan be introduced at the treatment site. Other substances but notlimited thereto, which may be introduced at the site include variousscarring agents, rapamycin and its analogues and derivatives, paclitaxeland its analogues and derivatives, phytochemicals, alpha-1a-adrenergicreceptor blocking agents, smooth muscle relaxants and other agents thatinhibit the conversion of testosterone to dihydrotestosterone.

A terminal end portion 48 of the tubular housing assembly 24 of theanchor deployment device 20 includes a nose assembly 50 shaped toprovide an atraumatic surface as well as one which facilitates desiredpositioning of components of an anchor assembly (See FIG. 2A). That is,by including structure that can mimic the ultimate position of aproximally oriented component of an anchor assembly, an operator cantest the effect of the anchor assembly prior to implantation. Once theoperator confirms that the subject anchor component will be positionedas desired, the implantation of the anchor is then undertaken andaccomplished.

Once implanted, the anchor assembly 51 (See FIGS. 2B and C) of thepresent invention accomplishes desired tissue manipulation, compressionor retraction as well as cooperates with the target anatomy to providean atraumatic support structure. In particular, as shown in FIG. 2C, theshape and contour of the anchor assembly 51 can be configured so thatthe assembly invaginates within target tissue, such as within naturalfolds formed in the urethra by the opening of the urethra lumen by theanchor assembly. In fact, in situations where the anchor assembly isproperly placed, wispy or pillowy tissue in the area collapses aroundthe anchor structure. Eventually, the natural tissue can grow over theanchor assembly 51 and new cell growth occurs over time in the areasshown in FIG. 2C. Such cooperation with target tissue facilitateshealing and avoids unwanted side effects such as calcification at theinterventional site.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within anatomy can extract the best results. For example, whentreating a prostate, one portion of an anchor can be placed within anurethra. It has been found that configuring such anchors so that teno'clock and two o'clock positions (when looking along the axis of theurethra) are supported or retained, effectively holds the anatomy openand also can facilitate invagination of the anchor portion withinnatural tissue. This is particularly true in the regions of anatomy nearthe bladder and the juncture at which the ejaculatory duct connects tothe urethra.

Additionally, the terminal end portion 48 (FIG. 2A) includes a pluralityof spring biased, vertically stacked ring anchor components 52strategically positioned with respect to telescoping structure of thetubular housing assembly for the purpose of assembling an anchor device.As will be apparent from further description below, the stacked anchorcomponent 52 is one of two parts which form a second anchor component.To accomplish the biasing of the anchor components 52, a leaf spring 54is placed in apposition with the anchor component 52 that is at thebottom of the stack of components. Internal molded walls and bosses ofthe nose assembly 48 form a space to both receive the stacked anchorcomponents 52 as well as provide an area to retain the leaf spring 54and provide a base structure against which force supplied by the leafspring can be generated and transmitted to the anchor components 52.

As can be seen from FIG. 2A, terminal end portions of an upper tubularmember 56, a needle housing 58 and a telescope housing 60 are positionedwithin the nose assembly. Referring now to FIG. 2D, one can better seethe internal components forming the tubular housing assembly. Forrepresentation purposes, the outer sheath 44 is not depicted in FIG. 2Aand the internal components of the tubular housing assembly are shownseparate from the nose assembly and handle assembly. As shown, the uppertubular member 56, the needle housing 58 and telescope housing 60 extendlongitudinally. The outer sheath (not shown in FIG. 2A) covers asubstantial length of each of the upper tubular member 56, needlehousing 58 and telescope housing 60. Each of these structures alsoinclude internal bores, the upper tubular member 56 sized to slideablyreceive a pusher assembly (described in more detail below) and theneedle housing 58 sized to slideably receive a needle assembly 58 (alsodescribed in more detail below). Further, the telescope housing 60 issized to receive a conventional telescope (not shown), which in oneapproach, fills the entire space provided by the internal bore of thehousing 60. A cross-sectional view of a portion of the tubular housingassembly attached to the handle assembly 22 (with the nose assemblyremoved) is shown in FIG. 2F.

Turning now to FIGS. 2E and 2F, the internal components of the handleassembly will be described. In one preferred embodiment, the handleassembly 22 houses a needle assembly advancement and retractionsubassembly 66 that interacts with the movement of the first actuator.The first actuator includes a projection 68 extending through thehousing assembly 22 and is placed in operative association with theadvancement and retraction subassembly 66.

The needle assembly advancement and retraction subassembly 66 includesan outer collar 70 configured about an inner collar 72. Configuredbetween the outer collar 70 and an internal front surface 74 of thehandle assembly 22 is a first compressor spring 75. Placed within theouter collar 68 and between the inner collar 72 and an internal frontsurface 76 is a second compression spring 77. Additionally, attached tothe outer collar 70 is a lock assembly 78 which rotates between lockedand unlocked positions.

While the first actuator is in an open position (See FIG. 1), thecompression springs 75, 76 assume expanded configurations (See FIGS. 2Eand F). Also, the lock assembly 78 is in a disengaged or unlockedconfiguration. It is at this stage that the needle assembly (describedbelow) is in its retracted state and housed completely within the needlehousing 58.

One preferred embodiment of a first or distal component 82 is shown inFIGS. 3A and 3B. In an unconstrained configuration, the first componentforms a generally T-configuration (FIG. 3B). When constrained within ananchor delivery device, the first component defines a substantiallystraight member (FIG. 3A). While the component can be formed from anumber of materials and manufactured using various conventionalapproaches, it is contemplated that the component 82 be cut from anitinol tube using a laser. Using a superelastic material such asnitinol provides the component 82 with the resiliency to transformbetween a flipped T-configuration and a straight configuration.

As shown, the first component 82 includes a first portion 84 which atone end defines a cylindrical structure and at the other a partialcylindrical structure. When unconstrained, this first portion 84 forms aT-bar or top of the first component 82. A complementary partialcylindrical structure forms a mid-section or second portion 86 of thefirst component 82 and operates as a spring to accomplish the flippingof the first portion 84 between constrained and unconstrainedconfigurations. When the component is in its constrained, straight form,the second portion is positioned adjacent the first portion 84. A thirdportion 88 is also cylindrical in shape and extends from the secondportion 86 away from the first portion 84 of the first anchor component82. The third portion 88 slides freely with respect to a connector, theconnector being attached to the first portion 84 and a second anchorcomponent as will be described below.

One part of the second anchor component 52 is best seen in FIG. 3C(previously depicted as stacked anchor components in FIG. 2A). Thiscomponent is generally cylindrical in form and includes integrallyformed rings 90 spaced along an outer surface of the device, suchspacing can be varied as necessary for a particular purpose. The devicefurther includes a internal bore 92 which extends the entire lengththereof. A proximal end 93 of this part of the second anchor component52 includes an opening to the internal bore 92. The opening to the bore92 is surrounded by a first ring 90 and is sized to receive in a lockingarrangement the connector which will attach the first anchor 82 to thesecond anchor component 52. Additional rings 90 are spacedlongitudinally along an outside surface of the component.

As shown in FIG. 3D, a second part 98 of the second anchor component 52can be sized and shaped to both engage a connector and to lockinglyengage the first part. Although various forms of the second part 98 arecontemplated and described below, in one approach, the second part isgenerally cylindrical and includes a pair of spaced arms, the outerprofile being sized to fit within the internal bore 92 of the firstpart.

The connector 94 (See FIG. 3E) can be formed from any material whichprovides the desired holding force between first and second components.In one preferred embodiment, the connector is formed from conventionalconnector material for example monofilament polyester. In a preferredembodiment, the connector 94 is monofilament polyethylene terephthalate(PET). The connector material embodies desirable flexibility as well astensile strength. The monofilament PET size 2-0 is preferred because ofhigh tensile strength when tensioned and high column strength to pushthe series of parts 82 through and out the needle. In addition, themonofilament helps reduce or eliminate the possibility of infection. Assuch, when used as a connector 94, such material can be flexed at sharpangles to access various anatomical structures and surfaces and can alsobe relied upon to transmit necessary forces between the first and secondanchor assemblies. One or more first anchor components 82 can be affixedalong a length of the connector 94. Further, various approaches can beemployed to attach a first anchor component 82 to the connector. Forexample, the components can be affixed by an adhesive or can includetabs or other structure which is deformed into a locking arrangementwith the connector 94. Moreover, the anchor component 82 can simply becrimped directly to the connector 94 or the connector itself can includestructure which is complementary to that of the component to accomplishaffixation. It may be advantageous to employ an assembly capable ofhandling a connector equipped with a plurality of anchor componentsspaced along the connector since such a system has the ability toassemble and deliver multiple anchor assemblies without needing toreload.

One embodiment of a completely assembled anchor assembly 92 is depictedin FIG. 3F. In the embodiment shown, the assembly includes a singlefirst anchor component 82. In certain applications, however, it may bedesirable to employ a device having a plurality of spaced first anchorcomponents. Such spacing can be varied as desired for a particularapplication.

It is also contemplated that the completed anchor assembly is formedfrom components which are held together magnetically. For example, thefirst anchor component 82 and the second anchor component 52, 98 can beheld in place through magnetism and without the need of a connector. Insuch an approach, either both or one of the anchor components can be amagnet.

Moreover, as can be seen from FIG. 3F, the second anchor componentembodies the first part 52 which can be deployed from the stacked groupof such members housed within the terminal end portion 48 of the tubularhousing assembly 24 (See FIG. 2A), as well as the second part 98 which,by operation of the anchor delivery device 20 (described below),lockingly engages the first part 52.

As previously mentioned, a completed anchor assembly 96 can be employedto manipulate tissue and other structure found within a patient's bodyfor various purposes. In order to do so, the first anchor component 82is initially positioned in an apposition with a first body structure,such as the outer surface of the prostate capsule, and the second anchorcomponent assembly (52, 98) is placed against a second body structure,such as the inner surface of the urethra, the connector 94 holding thedesired spacing between the two body structures to accomplish thedesired manipulation.

Additionally, it is contemplated that all components of the anchorassembly 96 or selected portions thereof (of any of the anchorassemblies described or contemplated), may be coated or embedded withtherapeutic or diagnostic substances (e.g. drugs or therapeutic agents).Again, in the context of treating a prostate gland, the anchor assembly96 can be coated or imbedded with substances such as 5-alpha-reductasewhich cause the prostate to decrease in size. Other substancescontemplated include but are not limited to phytochemicals generally,alpha-1a-adrenergic receptor blocking agents, smooth muscle relaxants,and agents that inhibit the conversion of testosterone todihydrotestosterone. In one particular approach, the connector 95 canfor example, be coated with a polymer matrix or gel coating whichretains the therapeutic or diagnostic substance and facilitatesaccomplishing the timed release thereof. Additionally, it iscontemplated that bacteriostatic coatings can be applied to variousportions of the anchor assemblies described herein. Such coatings canhave various thicknesses or a specific thickness such that it along withthe connector itself matches the profile of a cylindrical portion of ananchor member affixed to the connector. Moreover, the co-delivery of atherapeutic or diagnostic gel or other substances through the implantdeployment device or another medical device (i.e. catheter), andmoreover an anchor assembly including the same, is contemplated. In onesuch approach, the deployment device includes a reservoir holding thegel substance and through which an anchor device can be advance to pickup a desired quantity of therapeutic or diagnostic gel substance.

The connector 94 can have associated therewith various structures whichfacilitate the attachment of anchor structures. Although intended forthe first anchor component 82, such structure can also be used for thesecond anchor component 52, 98. In one approach (FIG. 3G), the connector94 is coined 100 in a manner that provides structure to which an anchormember can form a locking engagement. As shown in FIG. 3H, structurefacilitating a locking engagement with anchor structure also can also bein the form of a ball-chain 102. Furthermore, a connector 94 can beequipped with crimped metal or other structures 104 for this purpose.

Turning now to FIGS. 4A-4I, various alternatives of first anchorcomponents 82 are presented. In particular, those depicted in FIGS. 4A-Ieach include a structure which flips to assume an angled or generallylateral configuration when the component is unconstrained. In aconstrained configuration, these components define a generallycylindrical profile (as shown in FIG. 4A).

Moreover, each of the various alternative embodiments can be formed fromconventional materials. In one aspect, the components can be formed bylaser cutting a nitinol tube. However, it is to be recognized that othermaterials and manufacturing approaches are also contemplated for exampleEDM of stainless steel.

For example, the connector shown in FIG. 4A includes a proximallyoriented collar 106 which is intended to be slid along a connector asthe second portion flips or rotates. A spring member 86 defines a bararm which forms a bridge between the collar 106 and a second portion 108which flips or rotates with respect to the collar 106 when the device isunconstrained as shown in FIG. 4B. In another approach (FIGS. 4C and4D), the spring member 86 forms a bridge between the collar 106 and asecond portion 108 which includes a pair of members which in aconstrained configuration extend in opposite directions along theconnector 94 and when unconstrained, form a T-bar structure. In yetanother approach (FIGS. 4E-F), the anchor component 82 can include apair of collars 106 configured between which are first and secondsprings 86. Attached to each spring 86 is a second portion 108, each ofwhich assume angled or lateral positions to thereby form an overallcross-like structure when unconstrained. Like the other embodiments, thecomponent defines a generally straight, cylindrical structure whenconstrained.

FIGS. 4G-I depict further embodiments of structures that can be employedas first anchor components 82 or alternatively, can be used solely asstructures for advancing the anchor assembly sub-components within theanchor delivery device or a patient's body. Each of these depictedstructures include various forms of tails 110 which can be employed toadvance the anchor components 82 through direct engagement with aterminal end of a pusher assembly (not shown) or for registering withinslots formed in a pusher assembly. These tails also help to flip, turnor angle the component 82 relative to connector 94. One embodiment ofthe tail (FIG. 4G) is a simple extension of a partial cylindrical memberwhich is bent away from the connector 94. Another approach (FIG. 4H)involves a long tail 110 which is folded against the connector 94 andyet another approach (FIG. 4I) involves a tail 110 that rather thanfolded against the connector includes a narrowed section which is bentaway from the connector and terminates to assume a beaver tail-likeshape.

With reference now to FIG. 4J, yet another embodiment of a first anchorcomponent 82 is presented. In this embodiment, the first anchorcomponent includes a full tube portion 107 connected to a half tubeportion 109 by a coiled portion 111. The device can further includeconnector attachment points formed along the full tube portion 109. Thecoiled portion 111 provides flexibility in multiple planes and thusfacilitates pushing the device through bends or angles formed in thedeployment device employed to deliver the first anchor component 82.

In a first step to deliver and deploy an anchor assembly for the purposeof manipulating tissue or other anatomical structures, the telescopedevice is employed to view the positioning of the device 20 at theinterventional site, for example, the tubular housing assembly 24 of thedevice is inserted into the penis of a patient and advanced until thedistal end 48 is adjacent an interventional site in the urethra (UT)adjacent the bladder (UB; See FIG. 5A). It has been found that amechanical solution to the treatment of BPH such as that of the presentinvention, can be more compatible with patients recovering from prostatecancer compared to energy-based solutions. Furthermore, the presentinvention also contemplates steps for sizing the anatomy. As it relatesto BPH treatment, the present invention also involves the placement ofan ultrasonic or other device in the patient's body, such as in therectum, to measure the necessary depth of insertion of the anchordeployment device within the patient's body. This information can beused to set or create a depth stop for the needle assembly so that theoperator can readily determine whether desired sections of the patient'sanatomy have been accessed. After so positioning the deployment devicewithin the patient, the first actuator 36 of the delivery device 20 (SeeFIG. 1) is then caused to be pivoted towards the handle assembly 22.Doing so causes the needle assembly 112 to be advanced distally and thenlaterally through a terminal end of the needle housing 58. The lockassembly 78 retains the needle in the advanced configuration (See FIGS.5C and D). It is to be noted that the lock assembly 78 can be configuredto automatically unlock or to require manipulation to disengage from alocking position. In a procedure to treat the prostate gland (PG) theneedle assembly 112 is advanced through the prostate gland to a firstimplant position (See FIG. 5E). Moreover, it is to be recognized thatfirst forked member 113 is translatable longitudinally either by hand orthrough action of a trigger or activator. In FIG. 5D, the first forkedmember 113 is shown retracted to more easily represent other systemcomponents, but in use, at this stage of deployment, the member 113 iscontemplated to be in an advanced position into engagement with slot115. Further, it is to be understood that for ease of systemrepresentation, second forked member 119 is shown in a truncated form,in that at this stage of deployment the terminal end of the member 119extends beyond the vertical stack of second anchor components 52,thereby holding the stack in a staged configuration. Finally, thepresent invention also contemplates a single member replacing the forkedmembers 113, 119 depicted, such a part of member 56 which can haveportions which provide the function accomplish by the terminal ends ofthe members 113, 119.

Notably, the needle assembly 112 has a generally tubular shape andterminates with a sharp point 114. A lumen extending the length of theneedle assembly 112 is sized to receive both components of the anchorassembly as well as structure for advancing the assembly through and outof the terminal end 114. Although various materials are contemplated,the needle assembly 112 is intended to be formed from resilient materialsuch as nitinol or other materials or polymeric substances. Moreover,although various angles are contemplated, in one approach the needlehousing 58 includes a distal section angled such that the needleprojects at angles approaching or at 90 degrees with respect to alongitudinal axis of the tubular housing assembly 24.

Once access is made at an interventional site to target tissue oranatomical structure and the first actuator is manipulated to advancethe needle assembly 114 to a desired position, the actuator is furthermanipulated to release the lock assembly 78 as well as to cause theinternal compression springs to retract the needle assembly. Note thatthe position of the first actuator 36 will return to the open position(See FIGS. 1, 2E and 2F). The result of this action is depicted in FIGS.5F, G, H, I and J. (Again, note that member 113 and 119 are shown inretracted or truncated forms in FIGS. 5F, G and H for clarity ofrepresentation.) That is, as the needle assembly 112 is retracted, thefirst anchor component 82 and connector 94 remain in an advancedconfiguration (FIGS. 5I and J). It is at this stage that the firstanchor component has been positioned as desired against a firstanatomical body structure (See FIG. 5J).

Contemporaneously with the retraction of the needle assembly 112, is thewithdrawal of the structure used to advance the first anchor component82 and connector structure 94 within the needle housing 58. In oneembodiment (See FIG. 5K), the advancing structure is in the form of apusher assembly 116. The pusher 116 can assume a generally cylindricaltube formed form a metallic or polymeric material which is sized andshaped to directly engage the first anchor component 82. Moreover, thepusher 116 could define a solid elongate member of polygonal or circularcross-section. Also, it can be configured to directly engage theconnector 94 directly or other structure formed on the connector 94 (SeeFIGS. 3G-I). In another aspect, the pusher can be sized to surround thefirst anchor member 82 and to engage a tail (See FIGS. 4G-I) forexample, of the anchor member once the pusher is pulled proximally withrespect to the anchor member. When the pusher 116 initially surroundsthe anchor member (or other structure formed directly on the connector94), the tail is held in compression, only to be released to extendlaterally from the connector when the pusher is moved proximally. Inthis way, the pusher assembly 116 can both be withdrawn when desired andadvance the anchor member 82 and connector structure 94 when necessary.In another approach, the tail can be held in compression by the internalsurface of the needle (not shown).

As shown in FIG. 5H, the complete withdrawal of the pusher 116 andneedle assembly 112 exposes the full length of connector anchorstructure for use in ultimately manipulating anatomical structures. Suchcomplete withdrawal involves both the pusher 116 and needle assembly tobe housed completely within the needle housing 58.

Alternative approaches for advancing anchor components within the anchordelivery device 20 are contemplated. That is, rather than having apusher assembly which surrounds an anchor component and relies uponengagement with a tail structure of an anchor component or otherstructure projecting from the connector member, other structure can beemployed to provide the ability to push and pull an anchor component. Inone such approach (See FIGS. 6A-C), the delivery device can be equippedwith a pusher member 116 in combination with a pull wire 118. The pushermember 116 in this approach remains proximal an anchor member 82 to beadvanced along the delivery device. Such anchor members 82 can be placedin a position distal the pusher, for example, by being released from acartridge configured distal to the pusher position or the deliverydevice can be a single use apparatus.

The anchor member 82, in turn, can include a proximal portioncharacterized by a pair of elastically or plastically deformable arms120 which in a first configuration are held to the pull wire 118 and ina second configuration, are released from the pull wire 118.Accordingly, the pusher member 116 is advanced with respect to the pullwires 118 to cause the arms 120 to become disengaged from the pull wire.In the embodiment shown in FIGS. 6A and B, the arms 120 are plasticallydeformable whereas the arms 120 of the anchor member 82 of FIG. 6C areelastically deformable. The elastically deformable arms 120 can beformed from resilient material such as nitinol. The plasticallydeformable arms 120 on the other hand can be made from less resilientmaterial.

Further alternative embodiments of pusher members 116 are shown in FIGS.6D-G. A pusher member 118 having a D-shaped cross-sectional profile iscontemplated for certain uses. Such a profile enables the pusher member116 to be placed along side the anchor component 82 and connector 94assembly, a distal portion of the D-shaped configuration engagingcomplementary structure on the connector assembly.

Also contemplated is a pusher assembly 116 which includes a side opening122 in communication with a lumen extending through the pusher 116 (SeeFIG. 6E). Threaded through the side opening 122 is a distal portion ofthe anchor component 82 and connector 94 assembly. In this arrangement,the distal-most anchor component 82 is placed against the terminal endof the pusher member 116 to accomplish advancement of the anchorcomponent 82 and connector 116 assembly as the pusher 116 is extendeddistally.

In yet another approach, as shown in FIGS. 6F and G, the pusher member116 includes a terminal end 123 configured with a D-shaped profilesuited to engage and advance an anchor/connector assembly 94. A proximalsection of the pusher 116 is equipped with a plurality of spaced detentsor cavities 124 sized and shaped to receive anchor components 82 orother structure formed on the connector 94. In this approach also, thepusher member 116 is configured to reside longitudinally adjacent theanchor/connector assembly 82, 94. Advancement of the anchor/connectorassembly 82, 94 is accomplished through an engagement between certain ofthe anchor/connector assemblies 82, 94 and the cavities 124.

Various measures can be taken to ensure proper loading of a first anchormember 82 within an anchor delivery device. In a first step, the anchormember 82 is loaded within an anchor protection cover 126 (FIG. 7A). Apusher member 116 is configured proximal to the connector 94 of thefirst anchor member 82 to accomplish advancement of the first anchormember 82 into and through the needle assembly 112 (See FIGS. 7B and C).This subassembly is insertable within a delivery device bay 128. Adistal portion 130 of an interior of the delivery device bay is equippedwith a conical taper configured to receive a distal complementaryportion of the anchor protection cover 126 thereby accomplishing thecentering of anchor member within the delivery bay 128. An internallumen extends the length of the protection cover 126 and the cover 126includes a ring seal 132 placed within a proximal end thereof. The ringseal 132 functions to hold the cover 126 on a pusher member 116.

The delivery device bay 128 can further include a bayonet lock mount 134that couples a spring loaded cartridge 136 to the delivery device bay128. Housed within the cartridge is a compression spring 138 configuredabout the pusher member 116. The spring cartridge 138 can also include alock-out structure 140 which operates to limit the tension placed on theanchor member 82 and connector 94 until the needle 112 is withdrawnsufficiently from the interventional site to avoid damage from theneedle 112 inadvertently engaging the anchor/connector assembly 82,94.That is, the pusher 116 includes a proximal end configured with ananchor deployment tab 142 that engages the lock-out structure 140,prohibiting the compression spring 138 from applying tension to theanchor/connector assembly 82, 94 before the needle assembly 112 is clearof the interventional site.

In another contemplated variation (FIG. 7D), the anchor delivery devicecan be fashioned with a multi-shooter anchor cartridge assembly 144. Onefeature of this approach is the involvement of a manifold 146 includingfour entries which feed into a lumen extending into a needle assembly112, each entry configured to receive one anchor/connector assembly82,94. Proximal sections of the connector 94 are configured into spools148 which are driven by a torsional spring drive shaft 150. The driveshaft 150 is in turn, configured with complementary teeth structures 154formed on each spool. The assembly further includes structure (notshown) adapted to cause lateral movement in the driveshaft 150 so thatits teeth 152 indexes from spool to spool 148 to thereby turn the spools148 and advance the anchor members 82 within the needle assembly 112.Once the anchors 82 are advanced through the needle 112, the torsionspring retracts excess connector 94 length and clears the needle 112 forthe next anchor member 82.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Although various sections ofthe device can include such devices, in the depicted structure of FIG.7E, sensors 156 can be placed along the needle assembly 112. In thisway, an operator can detect for example, whether the needle has breachedthe target anatomical structure at the interventional site and theextent to which such breaching has occurred. Other sensors which candetect particular environmental features can also be employed such asblood or other chemical or constituent sensors. Moreover, one or morepressure sensors or sensors providing feedback on the state ofdeployment of the anchor assembly during delivery or after implantationare contemplated. For example, tension or depth feedback can bemonitored by these sensors. Further, such sensors can be incorporatedinto the anchor assembly itself, other structure of the deploymentdevice or in the anatomy.

In a next stage of anchor deployment, with reference to FIGS. 8A-E,after the first actuator 36 is completely released thereby effecting thecomplete withdrawal of both the needle assembly 112 and pusher member116, the second actuator 36 is pulled proximally to initiate theassembly of the second or proximal anchor member 52,98 (See FIG. 8A).Note that in FIGS. 8C, D and E, member 113 is shown in its advanced orforward position within slot 115, wherein member 119 is shown with itsterminal end truncated. With reference to FIG. 8B, which depictsinternal components of the integrated anchor assembly associated withthe second actuator (other structure being removed for betterunderstanding), as the second actuator 36 is depressed, it engages alever assembly 120 including a slotted portion 122 to drive a rackassembly 124 distally. The slotted portion 122 of the lever assembly 120provides the lever with the ability to both rotate with respect to amount 126 of the rack assembly 124 as well as advance the mount 126 aswell as the rest of the rack assembly 124 distally. Various pawls 130are provided to releasably lock the rack assembly 124 in desired stagesof advancement. It is to be recognized, however, that various otherapproaches to manually locking or unlocking structure for advancingcomponents of the second anchor assembly are contemplated. In thedepicted embodiment, the rack assembly 124, is in turn, connected to atelescoping pusher member which is configured to engage a second part ofthe second or proximal anchor assembly.

As shown in FIGS. 8C-E, depressing the second actuator 38 causes apusher 157 to advance a second part 98 of the second or proximal anchormember to be advanced towards and into locking engagement with the firstpart 52 of the second anchor member. As the second part 98 is advanced,it captures the connector structure 94 and retains it in a lockingengagement between the first 52 and second 98 parts.

It is at this stage that the connector 94 is severed to therebyaccomplish the formation of the complete anchor assembly (See FIG. 3E).In one embodiment, the severing can be effected by the advancement ofthe telescoping pusher member via the depression of the second actuator38. Alternatively, the severing action is operatively associated withthe actuation of the third actuator 40. Thereafter, the second actuator38 is released, automatically or manually, to permit the re-staging ofboth the first 52 and second 98 parts of the second anchor member. Thatis, in one contemplated approach, members 113 and 119 are withdrawn toallow the release and deployment of the second anchor member 52, 98 andthen advanced again after the desired staging of component 52.

The present invention also contemplates a myriad of alternativeembodiments of the proximal or second anchor member. In a majority ofthe next presented descriptions regarding these embodiments, the secondanchor member is comprised of a first part 52 which is placed into alocking engagement with a second part 98. In doing so, the first 52 andsecond parts 98 are affixed to the connector 94. It is to be recognizedthat the first and second parts can be formed of any conventionalmaterials such as metals or polymeric materials.

With reference to FIGS. 9A-C, the second anchor member includes agenerally tubular first part 52 including a slightly flared mouthconfigured to receive both a portion of the connector 94 and a secondpart 98. In this embodiment, the second part includes a pair of spacedarms 158 which capture the connector and facilitates advancing theconnector within the mouth of the first part. It is contemplated thatthe arms 158 are spaced to an extent greater than an interior of thetubular first part 52 so that in combination with the area occupied bythe connector 94, a locking engagement between the first and secondparts is accomplished upon the full insertion of the second part 98within the first part 52. Thereafter, excess connector 94 length can becut away to form a complete second anchor assembly.

In a slightly modified approach (FIGS. 9D-9F), the second part 98includes a spike-like terminal end portion 160 which can be configuredto engage the connector 94 and insert it within an interior of a tubularfirst part 52. The spike-like terminal end portion 160 defines a taperedstructure, a section with an enlarging dimension of which is sized andshaped to lockingly engage with the interior of the first part 52. Thecompleted assembly is characterized by a portion of the connector 94retained between the first 52 and second parts 98.

The approach depicted in FIGS. 9G and H is slightly different. Theconnector 94 is arranged to be threaded through a pair of oppositelyarranged apertures 162 formed in a generally tubular first part 52. Thefirst part 52 further includes a mouth equipped with a plurality ofproximally oriented, radially spaced arms 164. The second part 98 alsodefines a generally tubular structure, one having a section with asmaller outer profile than an interior of the first part 52. The secondpart 98 further includes a pair of distally oriented projections 166 aswell as a back end equipped with a gear-like collar 168. To accomplish alocking arrangement between the first 52 and second 98 parts, the secondpart 98 is inserted within the first part 52 so that the projections 166are configured on opposite sides of the connector. The collar 168 isthen used to rotate the second part 98 with respect to the first partuntil the connector 94 defines an S-shaped portion within an interior ofthe first part. The second part 98 is thereafter fully inserted into thefirst part, the gear-like collar being configured to register betweenthe radially spaced arms 164 of the first part 52 to thereby lock thetwo parts to each other. Furthermore, it is to be recognized that thesestructures of the first 52 and second 98 parts can be reversed in thatthe first part 52 can assume the structure of the described second partand vice versa.

The embodiments depicted in FIGS. 9I and J take a similar approach tothat shown in FIGS. 9G and H. That is, each take advantage of a lockingengagement resulting from the rotation of one part of the second anchormember with respect to the other. Again, each of these embodimentsinclude a first part 52 with pair of apertures 162 through which aconnector 94 is threaded. The assembly depicted in FIG. 9I includes afirst part 52 configured with internal threads 168 which arecomplementary to external threads 170 formed on a second part 98. Thus,as the second part 98 is placed within the first part 52, it is rotated,the complementary threaded portions forming the locking engagementbetween the two parts. The assembly of FIG. 9J takes advantage of asecond part 98 including arms 166 which are bent radially outwardly andthe bent portion being sized to facilitate a locking arrangement with aninterior of the first part 52. This particular approach is alsocharacterized by the first 52 and second 98 parts having roundedterminal ends which provide an atraumatic surface which can be desirablein certain situations. Again, the structures of the first and secondparts can be reversed if desired as can those of the followingapproaches.

As shown in FIG. 9K, another approach involves a first part 52 includinga pair of proximally oriented projections 172 which can be formed bysplitting longitudinally the mouth to the generally tubular first part52. The connector 94 is captured between the distally oriented spacedprojections 166 of the second part 98 and the proximally orientedprojections 172 of the first part 52 as the second part 98 is insertedwithin the first part 52.

In yet another approach (FIG. 9L), the second part 98 is pre-loaded witha lock ring 174, which is oriented about the second part 98 at aproximal end portion thereof. As the second part 98 is advanced over aconnector and into engagement with a first part, its spaced arms 166enter an interior of the first part. Once the second part 98 is seatedwithin the first part, the lock ring 174 is then advanced over thesecond part 98 to accomplish a locking arrangement.

The first part 52 can also define a generally tubular member having anoval cross-sectional profile. Such a structure is depicted in FIGS. 9Mand N. Further, one of the oppositely oriented apertures 162 formed inthe first part 52 can further include a slotted-portion 172 sized toreceive a portion of a connector after the first part 52 is placed in alocking arrangement with the second part 98. The first part 52 furtherincludes a pair of openings 178 configured on opposite lateral sides ofthe device. In these embodiments, the second part 98 defines arelatively flat member, the distally oriented arms 166 of which includeprojections 180 having a ramped portion. Although different structure isemployed, both embodiments of the second part 98 further include asecond pair of projections 182 formed at proximal end portions of therespective devices. As the second parts 98 of these approaches isadvanced within the first part 52, the first projections 180 act tocompress the arms together then are advanced past the lateral apertures178 of the first part 52 and are configured beyond a distal end (notshown) of the first part 52. Once the second part 98 is fully insertedin the first part 52, the second pair of projections 182 register withinthe lateral openings 178 formed in the first part 52, thus forming alocking engagement.

The first part 52 can also be formed form a member having a deformable,enlarged mid-section 184 (See FIGS. 9O and P). In one approach, theenlarged mid-section 184 can be formed by longitudinally cutting aportion of the first part 52 and separating the material forming thisportion to define the opening 162 which is as before, intended toreceive a portion of the connector. As the second part 98 in the form ofa generally tubular sleeve is advanced over the first part 52, themid-section 184 is compressed, such compression effecting a lockingengagement between the first and second parts.

The second part 98 (See FIGS. 9Q and R) can also include laterallyspaced tabs 180 which slide within an interior of a generally tubularfirst part 52. The spaced areas 166 capture a portion of the connector94. Once the second part 98 is fully inserted within the first part 52,the laterally spaced tabs lock in place outside a proximal end of thefirst part 52. In the process, the portion of the connector 94 capturedby the arms 166 is compressed and held in place between the first 52 andsecond parts 98.

Turning now to FIGS. 9S-U, further approaches to accomplishing a lockingarrangement between first 52 and second 98 parts are presented. Theembodiment of FIG. 9S is characterized by a first part having agenerally oval cross-sectional profile and including both the firstlateral apertures 178 as well as a pair of oppositely oriented, secondlateral apertures 186. The second part is a generally flat membercharacterized by a proximal end configured with a stop in the form of aT-bar 184. As the second part 98 is advanced within the first part 52(not shown), the tabs 180 formed on the second part first registerwithin the first lateral openings 178. Thereafter, the second part isfurther inserted within the first part 52 to capture the connector whichis threaded through the apertures 162 formed in the first part 52. Yetfurther advancement of the second part 98 configure the detents 180within the second lateral openings 186 of the first part 52. Theproximal stop 188 is at this time placed in apposition with a proximalend of the first part.

In a similar approach (See FIGS. 9T-U), the generally flat second part98 includes both the first 180 and second 182 tab structures. As thesecond part 98 is advanced within the first part 52, the first tabs 180initially register within lateral openings 178 of the first part 52,which can act as a staging for subsequent advancement and capture of aconnector. Upon such subsequent advancement, the first tabs 180 are heldwithin an interior of the first part 52 and the second tabs 182 registerwithin the lateral openings 178 of the first part 52.

As shown in FIGS. 9V and W, the first part 52 can also assume a pin-likestructure with spaced arms 190. The second part 98 can define agenerally tubular structure including distally oriented arms 166.Insertion of the first part 52 within the second part 98 causes thespaced arms 190 of the first part 52 to compress about a portion of aconnector to form a locking arrangement. It is to be recognized thatthis approach to a locking arrangement can be modified in principle, inthat, as stated above, the structures of the first 52 and second 98parts can be reversed.

Moreover, the second part 98 can assume a generally tubular structureincluding a cutting projection 192 (See FIG. 9X) arranged to engage aconnector 94 upon insertion of the first part 52 within the second part98. In this way, further action beyond placing the first 52 and second98 parts into locking engagement, is not required to sever the connector94. Again, it is to be recognized that the structures of the first 52and second 98 parts can be reversed to also take advantage of thisapproach.

In a number of related approaches (See FIGS. 9Y-9AH), the second anchorcomponent can be formed of a single integral locking member 194. Certainof these members 194 are intended to be formed of plastically deformablematerial so that it can first assume a generally open configuration andthen be deformed to define a closed position in a locking arrangementabout a connector member. Alternatively, these members 194 can be formedof resilient material and be first held open and then allowed toself-collapse about a connector. In one such locking member (FIGS. 9Y),the integral member 194 is generally V-shaped and includes a pair ofdiverging arms 198 which can be arranged into locking contact with aconnector 194. Another locking member 194 (FIG. 9Z) is characterized bya clam shell profile, an interior of the arms 196 of which is suited tolock with a portion of a connector 94. The locking member 194 of FIG.9AA is also generally V-shaped and further includes a pair of divergingarms 196, one of which includes bosses 198 designed to mate withrecesses 200. A center section of one arm 196 is bent to provide spaceto receive a connector.

In FIGS. 9AB-AC, there is shown a plastically deformable locking member194 that is configured with a collapsible aperture 202. In an undeformedconfiguration, the aperture 202 is formed by walls defining a generallyhour glass shape. Applying a longitudinal compression force to thelocking member 194 causes the aperture 202 to collapse about and lockwith a portion of a connector 94, the walls deforming inwardly andengaging the connector 94.

The locking member 194 can also be embodied in a device including amid-section characterized by helically arranged members 204 (See FIGS.9AD-AE). The opening 202 defined by the helical member 204 is sized toreceive a connector member. This device can either be formed ofplastically or elastically deformable materials such that collapsing theopening 202 about a connector can be accomplished through theapplication of a force to the locking member 194 or by removing acompression force from the member.

In still yet other approaches (FIGS. 9AF-9AH), the locking member 194can be embodied in a member including diverging arms 196 projecting froma cylindrical base 204. One arm includes a boss or raised portion 198sized to fit within a recess 200. A mid-section of the device furtherincludes a generally circular space 206 defined by semi-circular cutoutsformed in the opposing arms 196. This space is sized to lockingly engagea connector when the arms 196 are in a closed configuration. The lockingmember 194 of FIGS. 9AG-AH also includes this circular space 206 definedby semi-circular cutouts formed in the diverging opposing arms 196 aswell as the locking projections 198. However, rather than thecylindrical base 204 of the embodiment of FIG. 9AF, the arms 196 and thelocking member 194 extend proximally beyond the circular space 206. Thisportion of the arms 196 also include a complementary projection 198 andrecess 200 arrangement.

In a related approach (See FIG. 9AI), the locking member 194 can bedeformed about a connector 94 employing an anvil 210. Such an anvilcustom designed for the various approaches can be employed to deform theprevious disclosed embodiments of other members. As the locking member194 is advanced within the anvil, angled surfaces within an interior ofthe anvil operate to close the arms 196 of the locking member 194.Narrowed portions 212 of the locking member facilitate such closing ofthe arms about a portion of the connector 94. Once the arms are insertedinto an interior cavity 214 of the anvil 210, a cutting blade 216 seversthe connector 94 to length as desired.

Turning now to FIGS. 9AJ-K, further embodiments of a second anchormember including a first part 52 and a second part 98 are presented.

In these approaches, the second part 98 includes arms 196 which arebiased to an open configuration. Using an anvil 210 housing a first part52 in the interior cavity 214, the second part 98 is caused to beinserted and held within the first part 52. In a first embodiment (FIG.9AJ), the arms 196 of the second part 98 are relatively long compared tothose of a second embodiment (FIG. 9AK). In both approaches, however, agenerally tubular first part 52 retains the arms 196 in a closedposition in locking engagement about the connector 94.

Returning to the concept of a second anchor member defining a lockingmember 194 (See FIGS. 9AL-AM), in still yet another approach thecapturing of the connector can be accomplished using a clip-likestructure. A pair of arms 196 begin at a proximal end of the device in aspaced arrangement. As the arms extend distally, they cross at mid-point218 beyond which a distal portion of the arms are adjacently arranged inapposition. One or both arms 196 can include a recess providing a spaceto allow the arms 196 to cross at the mid-point 218. Applying a force tothe proximal, spaced portion of the arms 196 causes the distal portionof the arms 196 to open. When opened, the arms 196 can be configured toreceive a connector. A closing force between the distal portion of thearms 196 of the locking member 194 accomplish locking the structure on aconnector.

The first part 52 of the second anchor member can also be configuredfrom a flat sheet of material into which a pattern is cut to formvarious slots and tabs (See FIGS. 9AN-AO). These first parts 52 can beformed of material which is capable of self-forming from the flatconfiguration into a generally tubular configuration when unconstrained.For example, material such as nitinol which has memory properties can beused to form such structure. A first contemplated flat pattern (See FIG.9AN) includes a central five sided aperture 222 on either side of whichare configured slots 224 cut in from lateral side edges of thestructure. In a second pattern (FIG. 9AO), the lateral slots 222 arereplaced with cutouts which define tabs 226.

Irrespective of the specific form of the anchor assembly, a next step inthe context of prostate treatment involves positioning the proximalanchor assembly 52, for example, within a desired section of the urethra(UT) of the patient (See FIG. 10A). Prior to doing so, the patient canbe monitored to determine whether there has been any evidence ofimprovement through the placement of the anchor. One such symptom iswhether there has been any urination. After so checking, the proximalanchor assembly 52 can be implanted. The patient is the again checkedfor evidence of improvement (i.e., flow improvement, visual appearance,opening of the urethra, urination, etc.). Next, the connector 94 issevered and the integrated anchor delivery device is withdrawn (See FIG.10B) and ultimately removed from the patient's body.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchor assembly as well as pushing directly uponthe connector of the anchor assembly. Moreover, as presented above, thedistal or first anchor component is advanced and deployed through aneedle assembly and at least one component of the proximal or secondanchor component is advanced and deployed through a generally tubularportion of the anchor deployment device. Further, both a single anchorassembly or multiple anchor assemblies can be delivered and deployed atan intervention site by the deployment device. Consequently, in thecontext of prostate treatment, the present invention accomplishes thecompression of both the urethra and prostate gland, the delivering of animplant at the interventional site, applying tension between ends of theimplant, and the invagination of the implant within natural tissue.Moreover, drug delivery is both contemplated and described as a furtherremedy in BPH in treatment.

An alternate embodiment of a distal portion of an anchor delivery deviceis shown in FIGS. 11A-C. FIG. 11A depicts the device in a stage ofoperation where the needle assembly 112 has been extended through theneedle housing 60 and configured to project laterally from a distal endportion 48 of the device and is in the process of being withdrawn overthe connector 94 and first anchor member 82 assembly. FIG. 11B shows theposition of the pusher assembly 116 once the needle assembly has beenfully retracted within the needle housing 58. A retractable cover 228shown in its advanced position includes a side aperture 230 throughwhich the needle 112 and pusher 116 assemblies can be advanced tothereby place the connector 94 in a position for engagement by first andsecond 98 parts of the second anchor member. To effect longitudinalmovement of the cover 228, a sliding arm 232 is provided and placed intoengagement with the cover. The sliding arm 232, in turn, is operativelyassociated with an actuator (not shown) pivotably attached to a devicehandle. In a further step of use (See FIG. 11C), the connector 94 issevered and equipped at its proximal end with one embodiment of a secondanchor member assembly.

In one particular approach (See FIGS. 12A-B), the delivery device can beequipped with an alignment tube 234 including inwardly directed tabs 236sized and shaped to be received into complementary recesses formed insecond parts 98 of a second or proximal anchor assembly. Such tabs 230not only provide structure for advancing the second parts 98 but it alsoensures proper rotational alignment of the second part 98 as they areadvanced to receive a portion of the connector and to lockingly engagewith a first part of the second anchor assembly.

With reference to FIGS. 13A-C, an integrated anchor 240 including aplurality of anchors 82 attached to each other by a connector 94 canalso be used to manipulate anatomical structures. In this approach, aneedle assembly 112 is utilized in a sewing motion to place variousportions of the integrated anchor 240 on opposite sides of anatomicalstructures to accomplish the desired manipulation at an interventionalsite.

The integrated anchor 240 can also be cut from a pattern (FIG. 13F) toform a device which can assume a generally straight tubularconfiguration (FIG. 13D) for delivery to an interventional site. Once atthe site, the device can be permitted to deform a generally H-shape(FIG. 13E), a first portion 252 being placed in apposition with a firstanatomical structure and a second portion 254 configured against asecond anatomical structure. A mid-section of the device can include aspring-like structure 256 which is particularly suited for applying atension to the first 252 and second 254 portions.

One preferred embodiment of the anchor assembly of the present inventionis depicted in FIGS. 14A-D. In its unconstrained configuration, thefirst or distal anchor component 270 includes a first tubular portion272 which is generally orthogonal to a second tail portion 274. It is tobe noted, however, that while housed in a delivery assembly and prior todeployment at a target area, the first anchor component 270 isconstrained to define a generally straight configuration, onlysubsequently assuming the unconstrained configuration upon deploymentfrom the delivery device.

The tubular portion 272 of the first anchor component 270 includes aplurality of tabs 276 which can be deformed or deflected to accomplishaffixing the component 270 to a connector assembly 278 (See FIG. 14B).It has been found that three such tabs 276, two on one side of thetubular portion 272 and one on an opposite side provide a sufficientconnecting force and a desired balance between the connector 278 andfirst anchor component 270 and to move the first anchor component 270 byapplying a force either in the proximal or distal direction.

It is contemplated that the first anchor component 270 can be laser cutfrom a tube formed of nitinol or other appropriate material. Amid-section 280 of the component 270 provides a structural transitionfrom the tubular portion 272 to the tail portion 274. As such, a portionof a side wall is removed in the mid-section area 280. A further portionof the side wall is removed to define a connecting section 282 of thetail 274 which extends from the mid-section 280. This connector section282 acts as a spring to accomplish the relative unconstrained angleassumed between the tail 274 and tubular portion 272. A terminal endportion 283 of the tail 274 embodies structure having a surface areawhich is larger than that of the connector section 282 to therebyprovide a substantial platform for engaging tissue at a target site.

As shown in FIGS. 14C and D, the second anchor component 284 includes afirst part 286 and a second part 288. Once the first anchor component270 is positioned at a target site by employing a delivery device suchas that disclosed below (or previously), the second anchor component 284is assembled in situ.

The first part 286 of the second anchor component 284 includes aninternal bore 290 sized to receive a portion of the second part 288 ofthe second anchor component 284 in a locking engagement. An externalsurface of the first part 286 is sized and shaped to include a proximalcollar 291 spaced from a mid-section 292, each of which have generallycylindrical profiles. A smaller diameter, outer cylindrical portion 293is configured between the proximal collar 291 and mid-section 292 of thecomponent and a distal cylindrical portion 294 having yet a smallercylindrical profile defines a distal end thereof.

The second part 288 of the second anchor component 284 includes a solidgenerally cylindrical back end 295, extending from which are a pair ofspaced prongs 296. Terminal ends of the prongs 296 can be tapered toboth facilitate the insertion of the prongs 296 within the internal bore290 of the first part 286 as well as to receive a section of theconnector assembly 278. Notably, the prong structure commences at anarrowed slot 297 which steps outwardly to a wider dimension to therebydefine the space between the prongs 296. This narrow slot 297 providesthe second part 288 with desired structural rigidity to receive theconnector assembly 278 and to facilitate lockingly engaging theconnection between the first 286 and second 288 parts.

Thus, in its pre-implanted form, the anchor assembly can include oneanchor member (e.g., first anchor) whose initial engagement with aconnector is generally coaxial and another anchor member (e.g., secondanchor) with an initial engagement being generally perpendicular withthe connector.

Turning now to FIGS. 15A-H, there is shown one particular embodiment ofa linear, integrated anchor delivery device 300. The anchor deliverydevice 300 includes a handle assembly portion 302 and an elongate barrelportion 304 extending from the handle assembly 302 (See FIG. 15A). Whilevarious angles between the handle assembly 302 and elongate barrel 302are contemplated, in the embodiment depicted, the handle assembly 302and elongate barrel 304 are generally orthogonal. However, in certainapplications, it has been recognized that an obtuse angle between thesestructures can be advantageous when attempting to access anatomy (Seefor example FIG. 15H).

As depicted in FIGS. 15A and B, a handle casing 306 encloses internalcomponents of the handle assembly portion 302. The handle casing 306 issized and shaped to both fit comfortably in an operator's hand as wellas protect and provide supporting structure and space and channels forthe movement of the various internal components of the handle assembly302. In FIG. 15B, the casing 306 is removed to reveal the various gears,levers and racks which accomplish the anchor delivery function of theintegrated anchor delivery device 300.

In FIGS. 15C-E, outer tube 308 has been removed to provide a view ofinternal components defining the elongate barrel assembly 304. In oneembodiment, the outer tube 308 can be sized to define a 25 Fr., sheath.As will be developed below, the outer tube 308 is operatively associatedwith an outer tube connector assembly 309 which, in turn, is linked tolevers for advancing and retracting the outer tube 308.

With specific reference to FIG. 15C, the handle assembly portionincludes a top mount lever 310 connected at a top end to a link barassembly 312 and at a bottom end, includes an arcuate projectionequipped with teeth configured to engage complementary teeth of a first,small gear 316 of a connector/needle advance gear assembly 318. It is tobe recognized that the connector/needle advance gear assembly 318 isheld in place by a dowel pin or like structure passing through a centerof the assembly 318 and in fixed relationship to the handle casing 306when the delivery device 300 is in its fully assembled configuration.The top end of the top mount lever 310 is fixed within the handleassembly 302 to permit the lever 310 to pivot about the top end.

The top mount lever 310 further includes a looped mid-section portion320 sized to receive fingers of an operator's hand. By way of itspivot-point mounting and engagement between the arcuate extension 314and small gear 316, as the lever 310 is pulled proximally, the smallgear 316 is caused to rotate about its dowel pin mount.

The first, small gear 316 forms part of the connector/needle advancegear assembly which further includes a larger gear 322, to which thefirst, small gear 316 is affixed. Accordingly, as the top mount lever310 is depressed, both small and large gears 316, 322 rotate. As seen inFIGS. 15C-D, teeth of large gear 322 are configured to engagecomplementary teeth of a connector carrier rack 324. As the gears 316,322 rotate counter-clockwise, the connector carrier rack 324 movesvertically upward. FIGS. 15C and D depict the movement of the carrierrack 324 as the trigger assembly 310 is progressively depressed towardthe rack 324.

The connector carrier rack 324 includes a lower end portion 326 which isconnected to a needle return spring assembly 328. The connector carrier324 rack is permanently connected to the connector carrier block 336.The connector carrier block 336 is also operatively and releasablyconnected to both a needle assembly 330 and connector assembly 332 whichis threaded through the needle assembly 330. Various of the previouslydescribed embodiments of connector assemblies (See for example FIGS.3E-I and 14A-B) are contemplated for use with the anchor delivery device300. Both the needle assembly 330 and connector assembly 332 are, inturn, threaded through needle channel 334. As shown in the figures, theneedle channel 334 includes a curved portion residing in the handleassembly 302 and a distal section extending the length of the elongatebarrel section 304 of the anchor delivery device 300. Thus, the needleand connector assemblies are formed of axially flexible material so thatthey can easily navigate the turns in the needle channel 334.

The connector assembly 332 is releasably connected within the handleassembly 302 to a connector carrier block 336, which is itself attachedto the connector carrier rack 324. A releasable connection between theconnector block 336 and connector assembly 332 is accomplished by way ofa spring biased suture clamp (not shown) carried by the block 336. Alsoforming part of a connector advancement assembly is a connector carrier338 which can include a hypotube for receiving the connector 332. Aproximal end of the connector assembly 332 is looped about a connectortension and return spring assembly 340. The connector tension and returnspring assembly 340 can include various components such as negatorspring assemblies 342 and a C-shaped bar arm 344 which provide desiredtension on the connector assembly 332. In one aspect, one pound oftension force can be provided by the spring assembly 340; however, aslittle as a half pound and as much as five pounds of tension arecontemplated.

From its proximal end, the connector assembly 332 extends downwardlythrough the handle assembly 302 about a pulley 346 (See FIG. 15E) andback vertically within the handle 302. From there, the connectorassembly 332 extends through both the connector carrier block 336 andneedle assembly 330.

Further, the needle assembly 330 includes a proximal end portionattached to a needle rack 350. The needle rack 350 releasably engagesthe connector carrier rack 324 so that during a first part of thedepression of the trigger 310, both the connector assembly 332 and theneedle assembly 330 are caused to advance distally. During the finalstages of trigger 310 depression, the needle rack 350 disengages fromthe connector rack 324, thereby allowing the relative movement of theconnector assembly 332 with respect to the needle assembly 330. In thisway, the anchor structure (See for example, FIGS. 14A and B) attached tothe connector assembly 332 can be placed beyond a terminal end of theneedle assembly 330 and against a target tissue within a patient's body.

In order to accomplish such action, the handle assembly 302 is equippedwith a needle stop assembly 360 including a release tab 362 whichconstrain connector carrier block 336 thereby rigidly connecting theconnector carrier block 336 to the needle rack 350. As the connectorcarrier rack 324 is moved vertically upward the connector carrier block336 moves out of contact with the release tab 362 thereby permitting theconnector carrier block 336 to uncouple from the needle rack 350. Afterthe connector carrier block 336 is out of contact with the release tab362 the needle rack 350 collides with the needle stop assembly 360thereby causing the connector carrier block 336 to uncouple from theneedle rack 350. Thus the disengagement of the needle rack 350 from theconnector carrier rack 324 allows the connector assembly 332 to beadvanced while the advancement of the needle assembly 330 is ceased. Thedepth of deployment of the needle assembly 330 can be adjusted byaltering the vertical position of needle stop assembly 360. This may beaccomplished with a spring-loaded sliding switch that connects theneedle stop assembly 360 and the handle casing 306 (not shown).

As the connector carrier rack 324 moves vertically upward it repeatedlyengages the needle advancement ratchet 366 which is maintained in afixed position relative to the handle casing 306. The needle advancementratchet contains a ratchet component and a spring element (not shown)that permits only upward vertical movement of the connector carrier rack324 when the spring element is in a first position. As the top mountlever 310 is progressively depressed, it comes in close proximity withand then engages a junction connecting a pair of toggle links 368. Thetoggle links 368 each include a first end pivotally connected to theother toggle link. A second end of an upper toggle link is pivotallyconnected to an upper end of the connector carrier rack 324. A secondend of a lower toggle link is operatively associated with the needleadvancement ratchet 366. As the top mount lever 310 engages the pivotconnector between toggle links 368, the spring element and the ratchetcomponent of the needle advancement ratchet 366 are moved into a secondposition that permits downward vertical movement of the connectorcarrier rack 324 thereby allowing subsequent retraction of the needleassembly 330 by the needle return spring assembly 328.

Once a distal portion of the connector assembly 332 is ejected from aterminal end of the needle assembly 330 and placed as desired within apatient's body, the trigger 320 can be manipulated to permit are-engagement between the needle rack 350 and connector carrier rack324. The needle return spring assembly 328 can then act to retract theneedle assembly 330 back within the anchor delivery device 300. Duringthis procedure, the negator spring assembly 340 continues to provide adesired tension on the connector assembly 332. Moreover, during thisparticular juncture, the connector assembly 332 can be disengaged fromthe connector block 336 until the block returns to a default position.

Proper placement of the distal end of the connector assembly 332, aswell as all steps involving the anchor delivery device 300, can beobserved and ensured by a scope assembly 370. The scope assembly 370extends from a upper back end of the handle assembly 302 and distallywithin a tube assembly 372 extending along structure defining theelongate barrel assembly 304.

With the distal end of the connector assembly 332 placed at a desiredinterventional site and the needle withdrawn within the anchor deliverysystem 300, the operator selects a site for delivering and implanting aproximal end of the anchor assembly. After positioning a terminal end ofthe elongate barrel 304 at the selected location, the operator actuatesstructure to first engage a proximal end portion of the connectorassembly 332 extending from the anchor delivery device 300 with aproximal anchor assembly and then severs the connector assembly 332 to adesired length. The multitude of various alternatives of proximal anchorstructures are depicted in FIGS. 9A-AO and 14C-D.

Accordingly, with reference to FIGS. 15F and G, the handle assembly 302includes a second trigger assembly 380 which is operatively associatedwith an anchor pusher assembly 382 which when translated, engages onecomponent of a proximal anchor assembly against another (not shown). Inone contemplated approach, depressing the second trigger 380 causes thepivoting of an intermediate link arm 384 which is connected via a slotto a projection extending to a pusher rack 386. The pusher rack 386 isin turn connected to the anchor pusher 382.

Subsequent to the depression of the second trigger and the locking of aproximal anchor component (not shown) onto the connector assembly 332 toform a completed anchor assembly, the connector assembly 332 must be cutto length. First, the second trigger is released allowing the pusherrack 386 to return to its home position. Next, structure is activated toadvance the outer tube to sever the connector assembly 332.

To accomplish the cutting of the connector assembly 332, the linearintegrated anchor delivery device 300 is provided with the outer tubeassembly 308. This outer tube assembly 308 can be translatedlongitudinally in directions to and away from the handle assembly 302 byactivating a front lever 390. The front lever 390 extends from a top ofthe handle assembly 302 and pivots front and back along a surfacethereof.

Moreover, the front lever 390 is connected to an outer tube rackassembly 392 which includes an outer tube safety lever system 394. Alever lock assembly 398 is also provided as well as a cam plate 402.

Thus, once unlocked, pivoting front lever 390 rearward advances theouter cover. Such action accomplishes the severing of the connectorassembly 332 to a desired length by a shearing action of a sharpintegrated element of the outer cover (1086 FIG. 2A). The anchordelivery device 300 can then be removed from the interventional site orit can be used again to implant another anchor assembly.

With reference now to FIGS. 16A-G, there is shown yet another integratedanchor delivery device 500. The device 500 includes a handle assembly502 and an elongate barrel assembly 504 extending from the handleassembly 502. As best seen in FIGS. 16B and C, the handle assembly 502includes a handle casing assembly including a left handle casing 505 anda right handle casing 507. The handle casings 505, 507 both enclose aswell as provide substructure support and mounting structure for theinternal mechanisms of the handle assembly 502.

Turning now to FIG. 16D, the various internal components forming thehandle assembly 502 will be described. As with the previously describedembodiments of the integrated anchor delivery systems, the device 500shown in FIG. 16D is employed to deliver distal and proximal componentsof an anchor delivery device as well as to assemble the proximalcomponent in situ. Moreover, the delivery device 500 includes structureto cut the anchor assembly to length and apply a tension duringimplantation between the distal and proximal anchor components thatremain after implantation between the distal and proximal anchorcomponents. Further, a scope is included to provide remote viewing ofthe process of anchor assembly and implantation.

Accordingly, the integrated anchor delivery device 500 includes a distalanchor trigger 506 including a top end rotatably mounted within thehandle assembly 502 and a lower end equipped with an arcuate ring gearsection 508 including teeth. The ring gear section 508 is configured toengage a rotatably mounted gear assembly. More particularly, the gearsection 508 is positioned to engage a small gear 510 of the gearassembly. The small gear 520 is positioned adjacent a large gear 512 ofthe gear assembly and the small and large gears rotate in unison about acenter mount.

Moreover, a cam follower 514 is mounted within the handle assembly 502and placed in apposition with the arcuate ring gear section 508. Thus,the cam follower 514 supports the engagement between the ring gearsection 508 and large gear 512. Further, attached to a mid-section ofthe trigger 506 is a bar arm 518 (See also FIG. 16C). This bar arm 518is connected at its terminal end to a pawl assembly which will bedescribed in more detail below.

The large gear 512 of the gear assembly is adapted and configured tocooperate with a vertically arranged rack 520. The rack 520 includes alower end including a slot to fixedly engage a needle retraction springassembly 522. The needle retraction spring assembly 522 includes a pairof springs, each of which are placed into engagement with the rack 520.The rack 520 also includes an upper end portion which is configured tocooperate with a depth stop assembly (described below).

Additionally, the rack 520 is attached to a connector assembly carrierblock 524 (See also FIG. 16B) which releasably engages a connectorassembly 526 of an anchor assembly. Moreover, the rack 520 is attachedto a needle rack assembly 530 which engages a retractable needleassembly (not shown). From its connection with the needle rack 530, theneedle assembly extends vertically within the handle assembly 502 andthrough a needle support 532. The needle assembly then furtherretractably extends within a needle housing 534.

The needle rack 530 includes a lower section which releasably mates witha needle coupling pawl 540.

Further, from its connection with the connector assembly carrier 524,the connector assembly 526 first extends downwardly and then about apulley or spool 550. The connector assembly 526 exiting an opposite sideof the spool 550 extends upwardly and into engagement with a negatorspring 552. The negator 552 is in turn connected to a connector assemblytensioning system. The connector assembly tension system includes aspring 554 wrapped around a spring axle 556.

Configured adjacent and fixed to the spring axle 556 is a ratchet gear558. A pawl 560 including an extension received within a slot 562 formedin the bar arm 518 attached to the trigger 506 is also provided (FIG.16E). The pawl 560 cooperates with the ratchet gear 558 to offsetretraction forces generated by the connector assembly tension systemuntil the pawl 560 is removed from engagement with the gear 558.

It is to be recognized that the connector assembly tensioning systemscan be adjusted to provide a desired tension force. In one aspect, thisforce is set at approximately one pound but as little as a half a poundand as much as five pounds of force is contemplated.

The anchor delivery device 500 further embodies a depth stop assembly.The depth stop assembly includes three main components, namely, a depthstop rail 570, a lower end of which is connected to a depth stop bottom572 and an upper end of which is connected to a depth stop top 574.Notably, a free end of the depth stop bottom 574 includes a rampedportion 576 sized and shaped to engage the needle coupling pawl 540.

Accordingly, when the distal anchor trigger 506 is depressed (See FIGS.16D and E), the arcuate ring gear section 508 causes the small gear 510to rotate. By way of its being fixed to the small gear 510, the largegear 512 also rotates with the action of the trigger 506. Rotation ofthe large gear 512 causes the rack 520 to move vertically upward.Through connecting structures, the movement of the rack 520 advancesboth the connector assembly 526 and needle assembly (not shown) throughthe needle housing 534 and out a terminal end thereof. The advancementof the connector and needle assemblies is made against the spring forcesgenerated by the connector assembly tension spring 554 and needleretraction spring assembly 522.

Moreover, as the trigger 506 is depressed, the ramped portion 576 of thedepth stop bottom 574 engages the upwardly moving needle coupling pawl540 of the needle rack assembly 530. This engagement results intemporarily disengaging the needle rack 530 from the rack 520 beingdriven by the large gear 512. In this way, the depth stop assemblycontrols the distance which the needle is advanced beyond a terminal end580 of the needle housing 534.

Furthermore, upon the complete activation of the trigger 506, the bararm 518 slides horizontally inward while the pawl 560 engages teeth ofthe ratchet gear 558 attached to the spring axle 556 of the connectorassembly tension system. As the rack 520 is being translated vertically,the spring axle 556 and ratchet gear 558 rotate and the pawl 560 retainsthe rotational position of the axle 556 and gear 558. The pawl 560continues to hold the rotational position of the axle 556 and gear 558until the trigger 506 is completely depressed at which time theextension of the pawl 560 reaches the end of the slot formed in the bararm 518 and the pawl disengages from the gear 558. At this point, thegear is permitted to rotate freely in an opposite direction in responseto the spring force provided by the connector assembly tension springassembly.

It is to be recognized that the timing of the dual advancement of theneedle and connector assemblies and subsequent relative motion betweenthe assemblies is coordinated. That is, the needle assembly firstprovides access to an interventional site and then the connectorassembly is extended beyond a terminal end of the needle assemblythrough the relative motion of the needle and connector assemblies.

Moreover, it is at this stage that a distal component of the anchorassembly (not shown) is placed at a desired position within a patient'sanatomy. Such a procedure can be viewed using a scope 582 which extendsdistally from a back end of the handle assembly 502 and through atelescope tube 584. A distal terminal end of the scope 582 can bepositioned to so view the positioning of the distal and of the anchordelivery device 500.

The following will describe the steps involved in placing and/orassembling the proximal anchor component within the body as well assevering the connector portion of the assembled anchor assembly.

Thus, the integrated linear anchor delivery device 500 includes a secondor proximal anchor trigger assembly 590 (See FIGS. 16F and G)operatively associated with an anchor pusher assembly such as thatdepicted in FIG. 15C. A bottom end portion of the second trigger 590 isshaped to comfortably receive the finger of an operator. An upper end ofthe trigger 590 is forked, each forked member including a slottedportion 592 sized to receive one of a pair of horizontal extensionsprojecting from a pusher guide member 594.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can simply cut the connectorand simultaneously remove the second anchor previously implanted forexample, in the patient's urethra.

As the second trigger 590 is depressed, it rotates about a mid-sectionpivot fixed within the handle assembly. Such rotation causes the upperend of the trigger to turn forward thereby sliding the pusher guidemember 594 forward. The projections of the guide member 594 slide withinthe slots 592 provided in the upper end portion of the trigger 590. Byway of its direct connection thereto, a pusher (not shown) is advanceddistally. The forward advancement of the pusher is contemplated to actagainst one component of the proximal anchor assembly to therebyassemble it to another proximal anchor component and/or to the connectorassembly extending from the distal anchor component already placedwithin the patient.

Next, an outer cover lever 600 which is rotatably connected to a top endof the handle assembly is activated to sever the connector assembly. Itis to be recognized that the system accordingly has the capability tosever the connector at any time before or after the delivery and/orassembly of the second anchor. The lever 600 is connected to a slider602 having horizontal projections 604 located in slotted portions of thelever 600. The slider 602, in turn, is connected to a longitudinallytranslatable outer tube (not shown). Rotating the lever 600 forwardfunctions to advance the outer tube forward to thereby cut the connectorto a desired length. Thus, an anchor assembly is placed as desired at aninterventional site within a patient's body. The anchor delivery device500 can thereafter be used to implant additional anchors or it can becompletely removed from the body of the patient.

An aspect that the various embodiments of the present invention provideis the ability to deliver multiple, preferably four, anchor assemblieshaving a customizable length and distal anchor components, each anchorassembly being implanted at a different location without having toremove the device from the patient. The various embodiments provide forvariable needle depth and variable connector length for each of themultiple anchor assemblies delivered. Other aspects of the variousembodiments of the present invention are load-based delivery, preferably1 pound, of an anchor assembly, anchor assembly delivery with a devicehaving integrated connector, (e.g. suture), cutting, and anchor assemblydelivery with an endoscope in the device. The delivery device isuniquely configured to place such a load (half pound to five pounds)between spaced first anchor members as well as between or on animplanted first anchor and the delivery device. In this aspect, theneedle assembly acting as a penetrating member can be cooperativelyconnected to a mechanism which produces a desired tension between thevarious anchor members while the needle assembly is retracted. Moreover,this load can be accomplished between first and second implanted anchormembers.

It is to be recognized that various materials are contemplated formanufacturing the disclosed devices. Moreover, one or more componentssuch as distal anchor, proximal anchor, connector, of the one or moreanchor devices disclosed herein may be designed to be completely orpartially biodegradable or biofragmentable.

Moreover, as stated, the devices and methods disclosed herein may beused to treat a variety of pathologies in a variety of tubular organs ororgans comprising a cavity or a wall. Examples of such organs include,but are not limited to urethra, bowel, stomach, esophagus, trachea,bronchii, bronchial passageways, veins (e.g. for treating varicose veinsor valvular insufficiency), arteries, lymphatic vessels, ureters,bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

We claim:
 1. A system including an anchor delivery device and an anchorassembly for assembly within a patient's body, comprising: a firstanchor member; a second anchor member including a first part and asecond part; a connector joining the first and second anchor members;wherein the first and second parts are configured to be joined with theconnector and each other within a patient's body; wherein the anchordelivery device is configured to accomplish the assembly of the anchorassembly within a patient's body and to accomplish the implantation ofan assembled anchor assembly and wherein the anchor delivery deviceincludes a system that severs the connector.
 2. The system of claim 1,further comprising a scope.
 3. The system of claim 2, wherein the scopeextends substantially toward a terminal end of the anchor deliverydevice and provides a view of deployment and assembly of the anchorassembly.
 4. The system of claim 1, further comprising a safetymechanism that prohibits incorrect assembly of the anchor assembly. 5.The system of claim 1, further comprising a first actuator operativelyassociated with deployment of the first anchor member.
 6. The system ofclaim 5, further comprising a needle assembly, the needle assemblyconfigured to house the first anchor member, the needle assembly beingoperatively associated with the first actuator.
 7. The system of claim6, further comprising a first pusher assembly, the first pusher assemblybeing operatively associated with the first actuator and being placedinto engagement with the first anchor member.
 8. The system of claim 7,further comprising a relative movement assembly operatively associatedwith the first actuator, wherein actuation of the first actuatoraccomplishes the relative movement between the pusher assembly andneedle assembly.
 9. The system of claim 8, further comprising a secondactuator operatively associated with the assembly of the first andsecond parts of the second anchor member to the connector.
 10. Thesystem of claim 9, further comprising a second pusher assembly, thesecond pusher assembly being operatively associated with the secondactuator and being placed into engagement with one part of the secondanchor assembly.
 11. The system of claim 10, further comprising a thirdactuator configured to accomplish severing the connector.
 12. The systemof claim 11, wherein the third actuator releases the second anchormember or the anchor assembly from the anchor delivery device.
 13. Thesystem of claim 11, further comprising an outer tube assembly, the outertube assembly being operatively associated with the third actuator andconfigured to engage and sever the connector.
 14. The system of claim 1,wherein the anchor delivery device includes a penetrating member whichis extendable from the anchor delivery device.
 15. The system of claim14, wherein the first anchor member is delivered through the penetratingmember.
 16. The system of claim 15, wherein the second anchor member isdelivered without employing the penetrating member.